It’s official — FDA approves 2-PAM for use in children

September 11, 2010, 1:54 pm

This week the Food and Drug Administration announced that the agency has approved pralidoxime chloride (Protopam Chloride; 2-PAM) for use in children with cholinergic (organophosphate or nerve agent) toxicity. The antidote can be given by either intravenous or intramuscular routes.  The director of the FDA’s Office of Pediatric Therapeutics noted: “It can be difficult to use IV drugs in children, particularly in emergency situations, so having the new option of IM injection may help health care professionals use this medicine quickly and accurately”.

I have not been able to find details about the recommended dosing endorsed by the FDA. An excellent comprehensive review article (Pediatrics 2003;112:648) gives the initial pediatric dose of 2-PAM as 20-50 mg/kg to a maximum of 2000 mg/h. Adverse effects include dizziness, blurred vision, and hypertension.  Laryngospasm and rigidity have been associated with too rapid IV infusion of the antidote.

Thanks to Rogue Medic, who tipped me off that this approval had gone through and has also posted about it.

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